Drug Treatment May Be Obvious Even When FDA Is Unconvinced It Is Safe and Effective

| Jeremy Anapol


Before O’Malley, Reyna, and Chen. Appeal from the U.S. District Court for the District of Delaware.

Summary: The FDA’s acceptance of safety data for a prior-art drug when evaluating a claimed drug treatment was evidence of obviousness even though the data was insufficient to establish the safety and efficacy of the claimed treatment.

Persion Pharmaceuticals LLC (“Persion”) sued Alvogen Malta Operations Ltd. for infringement of patents directed to treating pain with an extended-release hydrocodone-only formulation in a patient with hepatic impairment (i.e., compromised liver functionality).

The district court found the asserted claims invalid as obvious in view of (1) prior art that disclosed the same hydrocodone-only formulation as the asserted patents, but for treating patients without hepatic impairment, and (2) prior art that disclosed treating patients with hepatic impairment using hydrocodone in combination with other active ingredients. The district court reasoned that one of ordinary skill in the art would have been motivated to administer the hydrocodone-only formulation to patients with hepatic impairment and would have had a reasonable expectation of success when doing so.

When evaluating the motivation to combine the prior art, the district court relied on evidence that the FDA accepted safety data for a hydrocodone-combination drug when it was evaluating the appropriate administration of the hydrocodone-only drug. On appeal, Persion argued that the district court’s reliance on this evidence was clearly erroneous because the FDA found that data insufficient to establish the safety and efficacy of the hydrocodone-only drug for treating hepatically impaired patients.

The Federal Circuit found no clear error in the district court’s analysis. The Federal Circuit affirmed the district court’s explanation that the standard to find a motivation to combine in an obviousness analysis is far below what is sufficient to prove safety and efficacy to the FDA. Thus, the FDA’s finding that the data for the hydrocodone-combination drug was insufficient to prove the safety and efficacy of the hydrocodone-only drug did not undermine the conclusion of obviousness. The Federal Circuit went on to address other attacks on the district court’s judgment but ultimately rejected them and affirmed the district court’s judgment that the asserted claims were invalid as obvious.

Editor: Paul Stewart